Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial

Not Applicable

Completed

• Conditions: Lateral Window Sinus Augmentation
• Interventions: Device: Allograft bone alone; Device: Allograft and xenograft mixture

• Registration Number: NCT03639077
• Lead Sponsor: University of Oklahoma

Brief Summary

The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.

Detailed Description

This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation.

Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Study Start: 2018-10-01
• Primary Completion: 2019-04-24
• Study Completion: 2020-09-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Adult patients ≥ 18 years old
2. In need of sinus augmentation utilizing lateral window sinus technique
3. Presence of bone height of < 8 mm
4. Patient has good oral hygiene (<40% plaque score)
5. Periodontally stable
6. Willingness to fulfill all study requirements

Exclusion Criteria

1. Currently smoking > 10 cigarettes / day
2. Pregnant, expecting to become pregnant or lactating mothers
3. Uncontrolled Diabetes Mellitus (HbA1c >7)
4. Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections)
5. Current use of oral bisphosphonates
6. History of IV bisphosphonates use
7. Poor oral hygiene (plaque score >40% based on O'Leary plaque score)
8. Unmanageable Sinus perforations
9. Significant pathology in the region of interest that may compromise the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allograft bone alone	Allograft bone alone	-
Allograft and xenograft mixture	Allograft and xenograft mixture	-

Primary Outcome Measures

Name	Time	Method
Graft volumetric stability change	CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material	CBCT will be the primary tool to evaluate the volumetric stability of the graft material used in the sinus augmentation procedure

Secondary Outcome Measures

Name	Time	Method
Histomorphometric analysis	After 6 months of sinus augmentation procedure when the implant is placed	Identify histological differences between two groups of graft material in sinus augmentation procedure

Trial Locations

Locations (1)

University of Oklahoma Graduate Periodotics; 🇺🇸 Oklahoma City, Oklahoma, United States